Nasopharyngoscope (Flexible or Rigid)

What Is This Device?

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

What Is FDA Product Code EOB?

Nasopharyngoscope (Flexible Or Rigid) is FDA product code EOB, Class 2, 21 CFR 874.4760.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 5 clearances under this code; the FDA took a median of 180 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 8 recalls under this product code since 2011. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (2) and Device Design (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.